| NCT ID | NCT06660277 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Chronic Kidney Disease Requiring Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,800 participants |
| Start Date | 2025-08-12 |
| Primary Completion | 2030-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4,800 participants in total. It began in 2025-08-12 with a primary completion date of 2030-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the health effects of expanded hemodialysis in patients receiving hemodialysis. The main question it aims to answer is: 1\) Does expanded hemodialysis reduce the risk of death from any cause? Researchers will compare expanded hemodialysis to conventional hemodialysis (the treatment currently used for the majority of patients receiving hemodialysis) to see if expanded hemodialysis works to improve patient outcomes. Participants will continue to receive their regularly scheduled hemodialysis treatments using either a super high-flux/expanded dialysis filter or a high-flux/conventional dialysis filter. All other aspects of treatments remain the same. No additional tests or visits are required. Data will be obtained using administrative healthcare databases and medical record review (at a subset of participating locations).
Eligibility Criteria
Inclusion Criteria: Inclusion requires that all the following are present: 1. One of: 1. Age 60 years or older; or 2. Age 45 to 59 years with a history of diabetes mellitus (Type 1 or Type 2) regardless of current glycemic status; and 2. Receiving any form of dialysis regularly for the previous 90 days; and 3. Currently receiving HD in-centre (main or satellite unit) 3 or more times per week; and 4. A valid provincial or territorial health insurance card number. Exclusion Criteria: Patients are ineligible if they meet any of the following criteria: 1. Not appropriate for this study in the opinion of the treating nephrologist or dialysis nurse practitioner due to any of: 1. Known or anticipated intolerance to the Nipro Elisio HX dialyzer; or 2. Planned to receive HDF; or 3. Planned to receive nocturnal HD; or 4. Anticipated to discontinue in-centre HD in the next 3 months for any reason (examples: palliation, transplantation, home dialysis, recovery of kidney function, death, others); or 5. Anticipated severe non-adherence to the frequency or duration of prescribed dialysis treatment; or 6. An overriding clinical preference for expanded HD (i.e., dialysis with the Elisio HX or other comparable dialyzer, such as Baxter TheranovaTM); or 7. Another medical, psychosocial, or logistical reason; or 2. Enrolled in another clinical trial that explicitly prohibits concurrent participation in other clinical trials or that would substantially interfere with adherence to the DIALEX procedures (note that DIALEX otherwise permits concurrent participation in other trials); or 3. Previously enrolled in this trial; or 4. Declined participation.
Contact & Investigator
Pavel S Roshanov, MD MSc FRCPC
PRINCIPAL INVESTIGATOR
London Health Sciences Centre Research Institute
Frequently Asked Questions
Who can join the NCT06660277 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, studying Chronic Kidney Disease Requiring Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06660277 currently recruiting?
Yes, NCT06660277 is actively recruiting participants. Contact the research team at pavel.roshanov@lhsc.on.ca for enrollment information.
Where is the NCT06660277 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06660277 clinical trial?
NCT06660277 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Pavel S Roshanov, MD MSc FRCPC at London Health Sciences Centre Research Institute. The trial plans to enroll 4,800 participants.
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